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Longitudinal Study of Children With a Chronic Cough and the Impact of Gastroesophageal Reflux

NCT00771706 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-04-20

No results posted yet for this study

Summary

Cough is both an important physiologic component of lung defense and a cardinal indicator of disease. For those with chronic cough, defined as cough lasting for more than 3 weeks, the differential diagnosis is broad, including self-limited, persistent, and chronic diseases. The success of a given treatment depends upon a proper diagnosis, yet this is often not obvious. Gastroesophageal reflux (GER) has been proposed as one possible etiology of a chronic cough in a number of studies in the adult literature; nevertheless a clear cause and effect remains to be confirmed as there continues to be no gold standard test definitively to identify pathologic GER. Each year, billions of dollars are directed towards diagnosing and treating GER as it relates to adults and children with a chronic cough but without solid proof of effect.

We propose to test the null hypothesis that there is no causative role of GER with regards to the etiology of chronic cough in children. If the null hypothesis proves true, this has important medical and economic ramifications, as it would suggest that treatment of acid reflux for chronic cough in a child is unwarranted. With this conclusion, health care costs would be reduced and children spared inappropriate medication.

Conditions

  • Cough
  • Gastroesophageal Reflux

Interventions

DRUG

Proton Pump Inhibitor

The PPI arm will consist of a two week course of PPI at a dose 1mg/kg/dose twice daily (minimum dose: 7.5 mg BID; maximum dose: 30 mg BID)

DRUG

Placebo

To compare the cough reduction rate using either PPI or placebo in children with a chronic cough.

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Principal Investigators

  • Christopher J Hartnick, MD · Massachusetts Eye and Ear Infirmary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-10-31
Completion
2008-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00771706 on ClinicalTrials.gov